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Ncircle(R) Nitinol Tipless Stone Extractor Ngage(R) Nitinol Stone Extractor

by Cook Incorporated

510(k) K120468

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120468↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK120468 Date6 Jul 2012ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ncircle Nitinol Tippless Stone Extractor and Ngage Nitinol Stone Extractor are flexible ureteroscopic retrieval devices designed for the removal of urinary stones. Constructed from nitinol, these devices feature a flexible, tip-less design to safely extract stones from the urinary tract without causing additional trauma.

These devices are supplied sterile and intended for single-use. They are classified under product code GCJ and are authorised under FDA 510K and MDR regulations. The Ncircle model lacks a distal tip to minimise risk during stone retrieval, while both devices are compatible with standard ureteroscopic systems for use in clinical settings requiring precise stone extraction.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of urinary stones can the Ncircle and Ngage Nitinol Stone Extractors be used to remove, and how does their design help during retrieval?

    Both the Ncircle Nitinol Tipless Stone Extractor and the Ngage Nitinol Stone Extractor are designed for the removal of urinary stones within the urinary tract. The Ncircle features a tip-less design, which reduces the risk of additional trauma during retrieval by eliminating a sharp distal end. This design is particularly useful for delicate procedures where minimizing tissue injury is critical. The Ngage model, while having a distal tip, is also flexible and compatible with standard ureteroscopic systems, allowing for precise stone extraction in complex anatomical areas.

  • Are these devices reusable, or are they intended for single-use only? If single-use, what does that mean for clinical workflows?

    The Ncircle and Ngage Nitinol Stone Extractors are intended for single-use only. This means each device is pre-sterilized by the manufacturer and should not be cleaned, reprocessed, or reused after a single procedure. Clinically, this simplifies workflows by eliminating the need for sterilization between cases, reducing infection risks, and ensuring consistent performance. Single-use also aligns with best practices for flexible ureteroscopic retrieval tools to maintain sterility and reliability.

  • How are these devices supplied, and what should clinicians check before using them in a procedure?

    The Ncircle and Ngage Nitinol Stone Extractors are supplied sterile in their packaging, ready for immediate use. Clinicians should verify the sterility seal is intact and unbroken before opening the packaging. Additionally, they should confirm compatibility with their existing ureteroscopic system, as both devices are designed to integrate seamlessly with standard systems for precise stone extraction. Proper storage (e.g., in a clean, dry environment away from direct sunlight) before use is also recommended to preserve functionality.

  • What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?

    The Ncircle and Ngage Nitinol Stone Extractors are authorized under FDA 510K and MDR (Medical Device Regulation) pathways, indicating they have undergone regulatory review for safety and effectiveness. The FDA 510K clearance (K120468) confirms they are deemed substantially equivalent to a legally marketed device, while MDR compliance ensures adherence to European Union standards. Clinically, this means they meet established benchmarks for ureteroscopic stone retrieval tools, providing confidence in their design and performance for use in procedures requiring precise and safe stone extraction.